ArticleNorth American Spine Society journal2026
Novel carbon fiber pedicle screw system for the treatment of lumbar degenerative disc disease: Results from a prospective, multicenter, FDA investigational device exemption study.
Article in North American Spine Society journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Standard titanium pedicle screw systems are widely used in spinal fusion but produce imaging artifacts and may have limitations in fatigue resistance. CarboClear carbon fiber-reinforced PEEK (CFR-PEEK) implants offer improved radiolucency and fatigue properties, and negligible artifacts in MRI and CT scans. The purpose of this study was to evaluate the safety and effectiveness of CarboClear CFR-PEEK pedicle screw system for patients with degenerative disc disease (DDD) undergoing 1 level lumbar spinal fusion. Methods: A prospective, multicenter, FDA-regulated Investigational Device Exemption (IDE) clinical trial, including 55 patients with DDD at 1 level (L2 to S1). Patients received the CarboClear System and a PEEK interbody fusion device. They were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, and 24 months, and then annually until the last patient completed 24-month follow-up. Primary outcome measures included self-reporting Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI), radiographic fusion rate, and safety assessments. Secondary measures included self-reporting SF-12 Health Survey (SF-12) scores and patient satisfaction (VAS), and operative parameters. Results were compared to predefined literature control group. Results: At 24 months, 90.0% of the patients had clinically meaningful pain improvement (VAS ≥ 20), and 78.0% had ODI improvement ≥15 points. Rigorously defined fusion was achieved in 85.71% of the patients at 24 months and in 94.59% at 36 months. The neurological success rate was 93.33%. No serious device-related adverse events occurred. The 24-month index-level reoperation rate was 7.14%, including 1 implant removal case (1.79%). Compared to the literature control, CarboClear device demonstrated superior imaging clarity and at least equivalent clinical outcomes. Conclusions: The CarboClear System is a safe and effective alternative to titanium pedicle screws for lumbar fusion, providing improved imaging compatibility and fatigue resistance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.